Regulatory Affairs Associate

Quality Engineer II

Location : Hercules, CA. (Hybrid)

7 month assignment (Great potential to extend)

Pay Rate : $45-$49 / hr. doe

On behalf of our client a leading manufacturing medical device company. We are seeking for a candidate that will be a part of the global PSUR Reporting Team.

Candidate will be facilitating business data collection, reporting efforts and generating periodic product PSUR / post market surveillance reports.

This includes regular interactions with area subject matter experts to ensure data is collected, documented, and analyzed.

Job Responsibilities :

• Facilitation and generation of product Post Market Surveillance (PMS) and PSUR reports.
• Use local and global systems to collect various post market information such as complaint, field corrective action and CAPA data.
• Analysis of post market data and reviewing completed reports with business partners.
• Maintaining and supporting databases and systems used for tracking various quality management system (QMS) activities related to post market surveillance.
• Maintain, archive and completed controlled quality records.
• Coordinate PMS and post market performance follow-up (PMPF) deliverables with internal business partners.
• Facilitate and / or chair local / regional PMS Board meetings.
• Support various QMS and PMS projects (local and global) as needed.
• Support internal / external audits as needed.

Education and Experience :

• Bachelor’s degree or equivalent in a related life science / technical / engineering discipline or equivalent preferred.
• 5 years’ experience in a regulated manufacturing industry or equivalent combination of education and experience.
• Understanding of GMP and quality system standards.
• Understanding of product post market surveillance requirements for IVD products a plus.
• Working knowledge of device / drug / biotech manufacturing processes.
• Experience with electronic QMS systems (i.e. Veeva, EtQ, Trackwise) a plus.
1 day ago

Salary : $45 - $49